Grants 101 July 28, 2017 I. NIH Structure & Behind the Scenes - - PowerPoint PPT Presentation

Grants 101

July 28, 2017

• I. NIH Structure & Behind the Scenes at Study Section

Tom Hawn

• II. Introduction to Research Administration at the UW

Monica Fawthrop

• III. Training & Career Development Awards

Sheila Lukehart

Outline

• 1. NIH Structure & Facts
• 2. Behind the Scenes at a Study

Section

• 1. NIH Structure & Funding

Getting the Facts

National Institutes of Health

US Department of Health and Human Services

Director of NIH Francis Collins, MD PhD

Secretary of H&HS The President

Responses to Yellow Fever

1879

• Yellow fever destroyed the Mississippi Valley
• A $30,000 bid (RFA) from the US Army for

Universities

• 1st peer-reviewed applications for research.

NIH History

Adapted from slide From Toni Scarpa, head NIH CSR

1887

• Marine Hospital Service established, NIH roots started
• Director Joseph Kinyoun

1930

• NIH officially named

The Fundamental Tenets for NIH (1946)

1. The only possible source for adequate support of our medical research is the taxing power of the federal government. 2. The federal government and politicians must assure complete

freedom for individual scientists in developing and conducting their

research work. 3.

Reviews should be conducted by outside experts essentially without

compensation. 4. Program management and review functions should be separated.

Surgeon General Thomas Parran, Jr.

Slide From Toni Scarpa, head NIH CSR

`

Department of Health and Human Services

Total Budget = $1092 Billion in 2016

FDA 3% Other 24 % HRSA 11% CDC 8%

NIH 54%

FY 2017 NIH Budget -- $34.1 Billion

Spending Outside NIH

Spending at NIH 2003: $27.1 billion 2004: $28.0 (+3.1%) 2005: $28.6 (+2.2%) 2006: $28.6 (-0.2%) 2007: $29.2 (+2.1%) 2008: $29.2 (0%) 2009: $30.4 (+4.1%) 2010: $30.8 (+1.4%) 2011: $30.7 (-0.3%) 2012: $30.6 (-0.3%) 2013: $29.2 (-4.5%,sequestration) 2014: $30.1 2015: $30.3 2016: $32.3 2017: $34.1 2018: $35.2 billion requested

Funding, Award and Success Rate Graph

Funding Rate: applicants, any award in the year Success Rate: A0+A1 applications combined Award Rates: A0+A1 applications separated

Top NIH Funded Institutions 2013

The Good News: UW Has Flourished

ORGANIZATION CITY STATE AWARDS FUNDING JOHNS HOPKINS UNIVERSITY BALTIMORE MD 1190 $573,828,199 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO SAN FRANCISCO CA 1189 $537,261,995 UNIVERSITY OF PENNSYLVANIA PHILADELPHIA PA 1083 $478,450,858 UNIVERSITY OF WASHINGTON SEATTLE WA 926 $423,942,137 UNIVERSITY OF PITTSBURGH PITTSBURGH PA 925 $419,326,750 UNIVERSITY OF MICHIGAN ANN ARBOR MI 986 $412,757,614 UNIV OF NORTH CAROLINA CHAPEL HILL CHAPEL HILL NC 901 $392,806,930 STANFORD UNIVERSITY STANFORD CA 849 $384,340,065 UNIVERSITY OF CALIFORNIA SAN DIEGO LA JOLLA CA 848 $382,491,697

Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32)

Stage of Research Training / Career Awards GRADUATE/ MEDICAL STUDENT POST DOCTORAL EARLY MIDDLE SENIOR CAREER

Predoctoral Institutional Training Grant (T32) Midcareer Investigator Award in Patient-Oriented Research (K24) Small Grant (R03) Research Project Grant (R01) Exploratory/Develop- ment Grant (R21)

Training and Career Timetable

Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25)

Pre-Bac

Pre-Bac Institutional Training Grant (T34) Mentored Career Transition (K22, PhD Eligible) NIH Pathway to Independence (PI) Award (K99/R00)

12

T & F Grants

• Institutional Awards: T32
• Institution, not the individual, applies for the award
• Not available at all schools, departments, divisions
• Individual Awards: F32
• Mentored
• Independent—can interact with other NIH Awards
• Depending on the award, all doctorates or restricted to clinical doctorates
• NIH support varies by Institute

TOTAL YEARS of F and T NIH Grant Support=3 YEARS

Kirschstein-NRSA post-doctoral fellowships (F32s) Competing applications, awards, and success rates

F32 NRSA Success Rates

UW Experience: Division of Pulm Crit Care 2006-16 21/38 funded (55%)

Good News: High Success Rates for Career Awards

2004 2005 2006 2007 2008 2009 2010 2014 Success Rates 36% 35% 31% 31% 35% 38% 36% 30% K08 40% 39% 34% 36% 44% 47% 44% 40% K23 36% 34% 27% 33% 38% 44% 38% 38% K99 100% 20% 23% 29% 25% 22% 2010 2015 2016 NHLBI K08 46 50.6 44.3% K23 42.0 38.3 44.6% NIAID K08 38 44.9 29.1% K23 56.0 34.4 40.5%

Part II: NIH Study Sections

1946 The First NIH Study Section An NIH Study Section Today

Outline

• 1. Pre
• 2. During
• 3. Post

• 1. Study Section Characteristics: NIH Structure

Office of the Director

National Institute

• n Alcohol Abuse

and Alcoholism National Institute

• f Arthritis and

Musculoskeletal and Skin Diseases National Cancer Institute National Institute

• f Diabetes and

Digestive and Kidney Diseases National Institute

• f Dental and

Craniofacial Research National Institute

• n Drug Abuse

National Institute

• f Environmental

Health Sciences National Institute

• n Aging

National Institute

• f Child Health

and Human Development National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute

• f Mental Health

National Institute

• f Neurological

Disorders and Stroke National Institute

• f General

Medical Sciences National Institute

• f Nursing Research

National Library

• f Medicine

Center for Information Technology Center for Scientific Review National Center for Complementary and Alternative Medicine National Institute

• f Allergy and

Infectious Diseases Fogarty International Center National Center for Research Resources Clinical Center National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities

NIH Institutes

http://www.nih.gov/icd/

No funding authority

Study Sections

• Organized into IRGs (Integrative Review

Groups)

• Headed by an SRO (Scientific Review

Officer)

• 12-25 members, essentially all from

academia

• About ½ are ad hoc reviewers
• 60-100+ applications per meeting
• ~10 per member
• 3 reviewers per applications
• Information from CSR web site:

http://cms.csr.nih.gov/

• Study section scope
• Roster of reviewers
• Policies
• Schedules
• Study sections are advisory - they do not

fund applications.

Scenario—Who to Ask at NIH

You are ready to apply for a grant and have many questions. Where do you get information? What do you apply for? 1. Study Section Chairperson 2. Grants Management Specialist 3. NIH Scientific Review Officer (SRO) 4. NIH Program Officer (PO)

Dual Review System for Grant Applications

 Second Level of Review  NIH Institute/Center Council

First Level of Review= CSR Scientific Review Group (SRG)

NIH owns review process

 The Scientific Review Officer, a

federal employee, nominates the review panel, assigns applications and is responsible for the meeting

Study section owns the science review Ownership of application:



• CSR from receipt to posting
• f Critiques



• Institute/Center after

Critique posting Except Ks Reviewed within Institute rather than CSR

The SRO and the Program Officer

 Scientific Review Officer (SRO)

– 240 SROs in CSR – Legal Responsibility for Study Section Mtg – Selection of Study Section Members – Assignment of Applications – Follow the law, the rules and the regulations – Assisted by Grants Management Specialist

 Program Officer

– Role before and after review – Key “translator” of summary statements for investigator

– Responsible for programmatic, scientific, and/or technical aspects of a grant.

Solicit Advice Broadly …

Mentor Fellows Post-docs Colleagues NIH

Review Process - Before the Meeting

• 4 months prior: Applications submitted
• 2 months prior: Applications assigned for review (~10 per person)

3 reviewers for each application (R1, R2, R3)

• 1 week prior: Scores and critiques are uploaded

Initial scores and critiques become available to all committee members

• Score revision phase
• 2-3 days prior: Applications are ranked in order of initial mean Impact Scores
• Lower 40-60% are not discussed (Impact Score of 4.5 – 5.0 and above)
• Any “triaged” application can be resurrected at the meeting for discussion for any

reason

• Applicants receive the critiques and individual criteria scores
• Impact Score is not given

90% of Grant Fates are Sealed Before the Meeting Begins

R Level Review Criteria

 Overall Impact : likelihood for the project to exert a sustained, powerful influence on

the research field(s)

 Scored Review Criteria: Determination of scientific merit: Impact scores

• 1. Significance
• 2. Investigator(s)

3.

Innovation

• 4. Approach

5.

Environment

23 Premise—Use this Word in Grant! Rigor & Transparency Sex as a Biological Variable

 Additional Review Criteria : can impact scores

• 1. Protection for human subjects (and inclusions)
• 2. Sex as a Biological Variable
• 3. Vertebrate animals
• 4. Biohazards
• 5. Resubmission, Renewal, Revision

 Additional Review Considerations: do not impact scores

• Select Agents
• Resource sharing plan: Data sharing, model organisms, & GWAS
• Budget
• Authentication of Key Resources

Scoring scale of 1 – 9 (Best to worst)  Budget: does not impact scores. Discussed after the final vote

Scored Review Criteria

• Overall Impact

Review Criteria

• Significance
• Approach
• Innovation
• Investigator
• Environment

Investigator Initiated R-series Grants

• Overall Impact

Review Criteria

• Candidate
• Sponsor, Collaborators,

Consultants

• Research Training Plan
• Training Potential
• Institutional Environment &

Commitment to Training

Individual Training F-series Grants

• Overall Impact

Review Criteria

• Candidate
• Career development plan

Career goals and objectives Plan to provide mentoring

• Research Plan
• Mentor(s), consultants,

collaborators

• Environment &

Institutional commitment

Career Development K-series Grants

Pre-Meeting Rank Order

App R1 R2 R3 Ave A 2 1 2 1.67 B 2 2 2 2 C 3 2 3 2.67 D 4 2 3 3 E 3 3 3 3 F 2 2 8 4 G 6 6 6 6 H 7 7 7 7 App R1 R2 R3 Ave A 2 1 2 1.67 B 2 2 2 2 C 3 2 3 2.67 D 2 2 3 2.33 E 3 3 3 3 F 2 2 4 2.67 G 6 6 6 6 H 7 7 7 7 ~1 Week Prior Badness #1 Badness #2 Read Other Reviews & Adjust Score ~3 days prior

Scoring System

• Criterion Score
• Whole numbers: 1-9
• 1 (exceptional); 9 (um, well let’s just hope you never get a 9)
• Given by reviewers but not discussed at study section
• Provided in Summary Statement of all applications (discussed and not

discussed)

• Overall Impact Score
• Whole numbers (at first): 1-9
• Not the mean of the criteria scores
• Different criteria are weighted by each reviewer
• Each review recommends a score
• All committee members score within the range
• Can vote outside the range, but must state that you are doing so
• Final Impact Score
• Mean of all scores x 10
• 10 – 90
• Percentiled against similar applications across 3 meetings (not so for F’s and

K’s)

• Unknown to the committee (except the chair)
• Payline
• Varies among institutes
• http://www.aecom.yu.edu/ogs/NIHInfo/paylines.htm

Adjectives Used

1 Exceptional 2 Outstanding 3 Excellent 4 Very Good 5 Good 6 Satisfactory 7 Fair 8 Marginal 9 Poor

Criteria Scores

Score Descriptor Additional Guidance on Strengths/Weaknesses 1 Exceptional Exceptionally strong with essentially no weaknesses 2 Outstanding Extremely strong with negligible weaknesses 3 Excellent Very strong with only some minor weaknesses 4 Very Good Strong but with numerous minor weaknesses 5 Good Strong but with at least one moderate weakness 6 Satisfactory Some strengths but also some moderate weaknesses 7 Fair Some strengths but with at least one major weakness 8 Marginal A few strengths and a few major weaknesses 9 Poor Very few strengths and numerous major weaknesses Minor Weakness: An easily addressable weakness that does not substantially lessen impact Moderate Weakness: A weakness that lessens impact Major Weakness: A weakness that severely limits impact

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CSR All 2014-01 Histogram

1. Shows recent scoring pattern of ~15,000 applications 2. Score is well spread over a range of ~10 - 69 3. In a regular study section panel, ~5% of applications get a score of 10-20 and about 2% perform poorly.

Where and When Do Reviewers Review Grant Applications?

• At home
• On a plane (likely no internet)
• At the last minute - and thus a bunch in one

sitting

• Hence, reviewers can be stressed, anxious,

& not terribly sympathetic

• They may lose interest

Don’t let the reviewer become… Baffled, Bitter,

• r Bored

Slide from Bill Parks

• Do not make the reviewer think!
• Do not make the reviewer read

papers or go to the internet

• Do not tick off the reviewers!

The Review Process - at the Meeting

• Begin at 8 am EST (i.e., 5 am PST)
• Cramped room full of lap tops and several jet-lagged

reviewers

• Review Grants in order - best to less best
• 15-20 min per application (shorter is best)
• Go to 6-7 pm
• Eat, sleep
• Repeat next day

The Review Process - at the Meeting

What happens?

• Application is announced and conflicts identified
• Chair asks the 3 reviewers to state their scores
• Primary reviewer:

Short description of proposal Discuss Overall Impact Discusses strengths and weaknesses using the scored criteria as a guide (but without stating criterion scores)

• Reviewers 2 & 3: concur or discuss differences
• Discussion opens to the committee
• Additional Review Criteria: Animals, Human Subjects, Resubmission, Authentication of

Resources

• Reviewers restate their scores (e.g., 2-4-5, 3-3-3)
• A range is established (e.g., 2-5, 3-3)
• Chair asks if anyone plans to vote outside of the range
• Committee posts scores online
• Additional Review Considerations: Budget, Resource Sharing, Bioethics training
• Repeat with the next application in order

Summary Statement

• Face Page
• Summary of Discussion
• Description (abstract you wrote)
• Overall Impact and Scored Criteria
• Addition Review Criteria
• Protection of Human Subjects
• Inclusion of Women, Minorities, and

Children

• Vertebrate Animals
• Biohazards
• Resubmission
• Additional Review Considerations
• Responsible Conduct of Research
• Budget
• Foreign Training
• Resource Sharing Plan
• Additional Comments to the Applicant
• Excess text in the wrong place
• Advice for resubmission

Individual Critiques

Vagaries of Peer Review

• Reviewers are humans; humans err
• Assigned reviewers have the most influence on scoring
• A passionate reviewer (pro or con) can influence the group
• Any committee member can vote outside of the “range”
• Final Impact Score is usually (~85% of the time) close to the

initial impact score

• Scores change >1 point on only 15% of grants
• Rarely for ESI applications (less than 1%)

Good video of a mock Study Section http://www.youtube.com/watch?v=fBDxI6l4dOA

Some Top Reasons Why Grants Don’t Get Funded

The Candidate Poor training potential. Poor productivity Uncertainty concerning future directions (where will it lead?). The Mentor not qualified, poorly funded, and/or not productive The Science Lack of new or original ideas. Diffuse, superficial, or unfocused research plan. Lack of knowledge of published, relevant work. Lack of preliminary data and/or experience with essential methodologies. Questionable reasoning in experimental approach. Absence of a sound hypothesis and clear scientific rationale. Unrealistically large amount of work. .

“…runs in our family. My father and grandfather are also working as postdocs.”

Reasons for Optimism Science is satisfying Science is important UW does better than average Career awards higher success

Additional Information

The NIH has put together a series of podcasts in their “All About Grants” webpage (see link below). It looks like a fantastic resource, especially for early stage investigators. General topics include: Getting to know NIH and the Grants Process Preparing a Successful Grant Application Advice for New and Early Career Scientists Submitting your Application How NIH Grants are Reviewed Life as an NIH Grantee (Post-Award Activities and Requirements) http://grants.nih.gov/podcasts/All_About_Grants/index.htm

Website References

NIH Grants Page: http://grants.nih.gov/grants/oer.htm NRSA (T+F Grants): http://grants.nih.gov/training/nrsa.htm K Career Development Awards: http://grants.nih.gov/training/careerdevelopmentawards.htm

Other Grant Sources To Consider

NIH Loan Repayment Program For individuals with clinical doctorate degrees working in specified areas of biomedical science, predominantly patient-

• riented research

Examples of Sources of Non-Federal Grants

American Heart Association Infectious Diseases Society of America Cystic Fibrosis Foundation Parker B Francis Foundation

NIH Award Mechanisms